Lifting bulk drug price controls could boost Indian clinical trials
India could enhance its status as a global player in clinical trials if plans to abandon bulk drug price controls go ahead.
Archives for November 23, 2011
FDA sends Mylan Puerto Rico plant a GMP warning letter
The US FDA has sent Mylan a warning letter after inspectors found GMP testing failings at its Puerto Rico facility.
Shire submits regulatory filings for Massachusetts Vpriv plant
Shire has submitted EMA and FDA regulatory filings to add ‘substantial manufacturing capacity’ for Vpriv (velaglucerase alfa).
Covance adding mass spec for biosimilars
Covance is adding mass spectrometry and other capabilities to meet growing demand for biosimilar comparability services.
EMA recalling oncology drugs manufactured by Ben Venue
The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.
GSK urges FDA to consider absorption of nanomaterials in new guidance
GlaxoSmithKline (GSK) has urged the US FDA consider the absorption of nanomaterials in the gastrointestinal (GI) tract within its proposal for new regulations on nanotechnology.
pSivida signs tech evaluation agreement for injectable implant
pSivida has inked a technology evaluation agreement with an unnamed global pharma over its Durasert drug delivery technology.